Orlistat EMA [Design Issues]

posted by Pharma_88 – India, 2020-11-27 14:51 (790 d 22:32 ago) – Posting: # 22089
Views: 1,108

Dear All,

This is regarding Orlistat for EMA submission. We have US product specific guidance available but I am unable to find EMA guidance (most probably its not there).

My question is whether is it required to add third arm (The reference product at 2 x 60 mg or 120 mg tid) as per US OGD for EMA? whether regualotry will accept this design as per FDA or 2WCO is sufficient (The test & reference product at 60 mg tid as crossover)?

thanks.

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